FDA UDI
In Commercial Distribution
🇺🇸 United States
SmartVest
DI: B102090700S0100
·
Model: SMARTVEST-HS
·
ELECTROMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SmartVest
- Primary DI
- B102090700S0100
- Version / Model
- SMARTVEST-HS
- Catalog Number
- SMARTVEST-HS
- Company Name
- ELECTROMED, INC.
- Labeler DUNS
- 036514250
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-02
- Public Version
- 1
- Public Version Date
- 2025-07-10
- Public Version Status
- New
- Public Device Record Key
- 0159a39d-3097-4f9b-9a2d-d4d1165da2eb
Device Description
Long term use (LTU) connecting hose
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYI | Percussor, Powered-Electric | Anesthesiology | 868.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38122 | Chest-oscillation airway secretion-clearing system vest | A tightly-fitting garment-like device that is a component of a high frequency chest wall oscillation airway secretion-clearing system and which is designed to be worn by a patient to encompass the thorax during high frequency chest wall oscillation (HFCWO) treatment. It is connected via a dedicated thick-walled hose to the system's generator which rapidly inflates and deflates the vest against the chest wall to promote airway clearance by creating HFCWO resulting in the mobilization of bronchial secretions. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B102090700S0100 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222496 | 000 |